[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603662":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":25,"studyPopulation":18,"armGroups":26,"interventions":33,"overallOfficials":18,"centralContacts":18,"locations":18,"responsibleParty":38,"collaborators":18,"id":40,"slug":18,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":18,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":62,"whyStopped":18,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":18},{"fullName":5,"class":6},"Nuwacell Biotechnologies Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"The Standardized Uptake Values (SUV) and %ID","The SUV and %ID of the injection site and various organs or tissues after PET\u002FCT imaging examination after local injection of \\[89Zr\\]-Oxine-NCR100 injection in subjects with knee osteoarthritis","Day2, Day8,Day12,and Day22",[14],{"measure":15,"description":16,"timeFrame":17},"Adverse Event(AE) or Serious Adverse Event(SAE)","Number of participants with treatment-related adverse events or serious adverse events assessed by CTCAE v5.0","Within 96 weeks of the infusion",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"NA","SEQUENTIAL","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE","Knee osteoarthritis(KOA) is a kind of degenerative joint disease characterized by chronic inflammation loss of articular cartilage and subchondral bone remodeling. This clinical trial aims to evaluate the biodistribution of 89Zr-labeled human pluripotent stem cell derived mesenchymal stromal cells (\\[89Zr\\]-Oxine-NCR100) injection in subjects with knee osteoarthritis after local injection and the kinetic behavior characteristics of the zirconium-labeled cells at the injection site and in various organs or tissues.",[27],{"label":28,"type":29,"description":30,"interventionNames":31},"NCR100 injection","EXPERIMENTAL","Subjects will receive a single injection of NCR100",[32],"Biological: NCR100",[34],{"type":35,"name":36,"description":30,"armGroupLabels":37,"otherNames":18},"BIOLOGICAL","NCR100",[28],{"type":39,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100603662",false,"NCT07139431","A Study of [89Zr]-Oxine-NCR100 Injection for the Cellular Distribution","A Study to Evaluate the Cellular Distribution of [89Zr]-Oxine-NCR100 Injection in the Treatment of Subjects With Knee Osteoarthritis","Distribution","Inclusion Criteria:\n\n* Subjects who understand and voluntarily sign the Informed Consent Form（ICF） before enrolment; Age: 40-70 years old, both genders; Men without reproductive intentions; Diagnosis of knee osteoarthritis based on American College of Rheumatology criteria.\n\nSubjects with KOA who have persistent pain for more than six months, Kellgren-Lawrence grade: II-III; McMaster University's Osteoarthritis Index (WOMAC) of the study-side knee joint: 60-180.\n\nExclusion Criteria:\n\n* Subjects previously diagnosed with secondary knee osteoarthritis, or those diagnosed with hip\u002Fankle joint disease requiring medical intervention; Subjects previously diagnosed with secondary knee osteoarthritis, or those diagnosed with hip\u002Fankle joint disease requiring medical intervention; Have received stem cell therapy; Experienced knee surgery, or plan to undergo knee surgery; Have used traditional Chinese medicine to treat KOA within 4 weeks; Have used intra-articular injection of drugs to treat KOA within 12 weeks; Received glucosamine, chondroitin sulfate, or diacetate therapy before investigational drug intervention within 12 weeks; Subjects with the acute phase of knee osteoarthritis; severe deformity of the knee; BMI≥30kg\u002Fm\\^2; Severe systemic infection or local knee joint infection; Have received systemic glucocorticoid therapy before intervention or need to take systemic glucocorticoid therapy during the treatment; Have serious heart disease； Subjects with peripheral or central nervous system disorders that may interfere with assessments; Have contraindications to Magnetic Resonance Imaging(MRI); Subjects with alcohol\u002Fdrug addiction\u002Fabuse or mental disorders; Have participated in other clinical trials within 12 weeks before the screening; Subjects with infection with hepatitis B virus(HBV), hepatitis C virus(HCV), HIV, and Treponema pallidum confirmed by laboratory tests; Subjects with a history of allergic reaction to any component of the trial drug or to acetaminophen; Subjects who are not suitable for PET\u002FCT examination.",true,"MALE","40 Years","70 Years",{"count":52,"type":53},6,"ESTIMATED","INTERVENTIONAL",[56],"PHASE1","This clinical study is to evaluate the biodistribution of \\[89Zr\\]-Oxine-NCR100 injection in subjects with knee osteoarthritis after local injection and the kinetic behavior characteristics of zirconium-labeled cells at the injection site and various organs or tissues. It is a single-dose, open-label study in adult KOA subjects.",[59],"KOA",[61],"MSC, KOA","NOT_YET_RECRUITING","2025-08-17",{"date":65,"type":66},"2025-08-24","ACTUAL",{"date":68,"type":53},"2025-08-29",{"date":70,"type":53},"2028-04-21",{"name":5,"class":6}]